RESPISENS

K092845 · Nomics · IYE · Jan 26, 2010 · Radiology

Device Facts

• Record ID: K092845
• Device Name: RESPISENS
• Applicant: Nomics
• Product Code: IYE · Radiology
• Decision Date: Jan 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

Device Story

Respisens system monitors patient motion during radiotherapy; utilizes magnetic distance sensor placed on thorax or abdomen to track breathing or verify immobility. System comprises measurement module, interface box, and user interface software. Interface box, located in control room, manages communication with PC, calculates signal display time lag, detects radiation beam status, and triggers alarms. Operator monitors real-time output on PC; system warns if breath hold is not maintained or if patient moves. Device is standalone, independent of therapy system; does not perform beam gating. Benefits include improved patient safety through real-time motion monitoring and verification of breath hold maneuvers.

Clinical Evidence

Bench testing only. Performance data demonstrated that the device achieves its intended use and performs comparably to predicate devices. Design, labeling, biocompatibility, electromagnetic compatibility, and electrical safety were verified. Software verification was performed.

Technological Characteristics

Magnetic distance sensor; standalone system; interface box for signal processing and alarm management; PC-based user interface. Complies with electrical safety and electromagnetic compatibility requirements. Software-based monitoring and alarm system.

Indications for Use

Indicated for monitoring patient motion, specifically breath hold and undesirable movement, during radiotherapy procedures to ensure patient safety.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• RPM Respiratory Gating system (K983629)
• RPM Respiratory Gating system (K063270)
• Active Breathing Coordinator - ABC system (K003330)

Submission Summary (Full Text)

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K092845

## 510(k) Summary

| Submitter's Name / Address: | NOMICS s.a. | JAN 2 6 2010 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Liege Science Park<br>Rue des Chasseurs Ardennais, 4<br>4031 - Angleur<br>BELGIUM | |
| | Tel: + 32 (0) 4 372 93 48<br>Fax: + 32 (0) 4 372 93 12 | |
| Contact Person: | Pierre Ansay (CEO) | |
| Date Prepared: | January 14th, 2010 | |
| Device Trade or Proprietary Name: | RESPISENS | |
| Common or Usual Name: | RESPISENS | |
| Classification Name: | Accelerator, Linear, Medical<br>CFR 892.5050<br>Class II<br>Product Code - IYE | |
| Predicate Devices: | RPM Respiratory Gating system (K983629)<br>RPM Respiratory Gating system (K063270)<br>Active Breathing Coordinator - ABC system (K003330) | |

#### Device Description:

The Respisens system monitors patient motion in real time during radiotherapy. The system is based on a transmitter/receiver that measures distance. When placed on the patient's thorax or abdomen, the system tracks breathing and thus helps monitoring and securing breath hold manoeuvres. If placed on a motionless part of the patient, it helps verify immobility. The underlying technology is a magnetic distance sensor that is capable of measuring movements with high sensitivity.

The Respisens system is composed of a Respisens measurement module and an Interface Box, their accessories, and a user interface software. The Respisens measurement module drives the sensor. The Interface Box is the control core of the system. It sits in the control room and handles the communication with the PC, the calculation of the time lag in signal display introduced by the PC, the detection of the status of the radiation beam, and the alarms.

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#### Intended Use:

The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

Both the Respisens system and the RPM Respiratory Gating system (K983629 and K063270) display and record patient respiratory motion during radiation therapy procedures and can be used to monitor the patient position. However, the new device does not start and stop the radiation beam in synchrony with the respiratory waveform (= gating) and therefore its indications for use are a subset of the RPM Respiratory Gating system. By comparison, the Respisens system and the ABC system (K003330), which also displays and records patient respiratory motion during radiation therapy procedures (but can not be used to monitor patient position), are alike in that they both are stand alone and independent of the therapy system and therefore do not offer the gating feature.

#### Technological Characteristics and Nonclinical Testing:

The layout and the technological characteristics of the new device are similar to those of the predicate devices. The Respisens system has been the subject of nonclinical testing to demonstrate that the differences, in particular in sensing technologies, do not adversely affect the safety or effectiveness of the device. Performance data have been submitted to show that the device achieves its intended use and performs comparably to predicate devices. Design, labeling, biocompatibility, electromagnetic compatibility, and electrical safety have been verfied to comply with applicable requirements. Software verification was also performed.

#### Summary of Substantial Equivalence:

The Respisens system is similar in intended use, layout, and performance characteristics to the predicate devices. The differences that exist between the devices do not raise new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract bird-like figures in flight, stacked one above the other. The emblem is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Pierre Ansay Managing Director Nomics S.A. WSL Liège Science Parc, Rue des Chasseurs Ardennais, 4 B-4031 Angleur BELGIUM ,

JAN 2 6 2010

Re: K092845

Trade/Device Name: RESPISENS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 15, 2010 Received: January 19, 2010

### Dear Mr. Ansay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Jrug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ed. Hf

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K092845

Device Name: RESPISENS

Indications For Use:

The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> OND Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Wolf

(Division Sign Off) Division of Radiological Devices

510(k) Number

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